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    01 Abiraterone Acetate (2)

    02 Budesonide (2)

    03 Cabozantinib (1)

    04 Ciclesonide (1)

    05 Clascoterone (1)

    06 Deflazacort (1)

    07 Desoxycorticosterone Pivalate (1)

    08 Dienogest (1)

    09 Drospirenone (1)

    10 Dutasteride (3)

    11 Etonogestrel (1)

    12 Exemestane (2)

    13 Finasteride (1)

    14 Fluticasone Furoate (1)

    15 Fluticasone Propionate (4)

    16 Fulvestrant (2)

    17 Ganaxolone (1)

    18 Halobetasol (1)

    19 Halometasone (1)

    20 Levonorgestrel (2)

    21 Medroxyprogesterone Acetate (1)

    22 Mometasone Furoate (4)

    23 Nomegestrol Acetate (2)

    24 Norelgestromin (1)

    25 Norgestimate (3)

    26 Oclacitinib Maleate (1)

    27 Palbociclib (1)

    28 Regorafenib (1)

    29 Ruxolitinib Phosphate (1)

    30 Segesterone Acetate (1)

    31 Trilostane (1)

    32 Umeclidinium Bromide (1)

    33 Vilanterol Trifenatate (1)

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    01 Active (25)

    02 Blank (24)

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    01 Expired (2)

    02 Valid (20)

    03 Withdrawn by Holder (2)

    04 Blank (25)

    filter

    01 219MF10017 (1)

    02 220MF10120 (1)

    03 222MF10142 (1)

    04 228MF10063 (1)

    05 228MF10133 (1)

    06 301MF10014 (1)

    07 302MF10123 (1)

    08 Blank (42)

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    01 Blank (49)

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    • FDA
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    Dienogest

    PDF Supplier PDF
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    USDMF

    Found USDMF

    37039
    Active
    DIENOGEST
    2022-04-06
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-158 - Rev 00
    Valid
    Dienogest
    2023-08-02
    Japanese DMF

    Found JDMF

    228MF10063
    Dienogest at Via Della Carboneria 3...
    2016-02-24
    Written Confirmation

    Close WC

    Application Number
    37039
    R1-CEP 2016-158 - Rev 00
    228MF10063
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    DIENOGEST
    Dienogest
    Dienogest at Via Della Carboneria 3...
    Issue/Submission Date
    2022-04-06
    2023-08-02
    2016-02-24
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    Fluticasone Propionate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    16423
    Active
    FLUTICASONE PROPIONATE
    2003-02-12
    CEP/COS

    Found CEP/COS

    R1-CEP 2005-268 - Rev 02
    Valid
    Fluticasone propionate
    2016-02-02
    Japanese DMF

    Found JDMF

    222MF10142
    Fluticasone Propionate at Via Della...
    2010-04-20
    Written Confirmation

    Close WC

    Application Number
    16423
    R1-CEP 2005-268 - Rev 02
    222MF10142
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    FLUTICASONE PROPIONATE
    Fluticasone propionate
    Fluticasone Propionate at Via Della...
    Issue/Submission Date
    2003-02-12
    2016-02-02
    2010-04-20
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    Mometasone Furoate

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    USDMF

    Found USDMF

    16648
    Active
    MOMETASONE FUROATE
    2003-06-16
    CEP/COS

    Found CEP/COS

    R1-CEP 2006-301 - Rev 04
    Valid
    Mometasone furoate
    2022-03-24
    Japanese DMF

    Found JDMF

    220MF10120
    Mometasone Furoate (Micronized) at ...
    2008-04-28
    Written Confirmation

    Close WC

    Application Number
    16648
    R1-CEP 2006-301 - Rev 04
    220MF10120
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    MOMETASONE FUROATE
    Mometasone furoate
    Mometasone Furoate (Micronized) at ...
    Issue/Submission Date
    2003-06-16
    2022-03-24
    2008-04-28
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    Mometasone Furoate

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    USDMF

    Found USDMF

    27022
    Active
    MOMETASONE FUROATE MONOHYDRATE (D90...
    2013-03-29
    CEP/COS

    Found CEP/COS

    R0-CEP 2018-185 - Rev 00
    Valid
    Mometasone furoate monohydrate
    2019-08-27
    Japanese DMF

    Found JDMF

    301MF10014
    Mometasone Fluorate Monohydrate at ...
    2019-06-05
    Written Confirmation

    Close WC

    Application Number
    27022
    R0-CEP 2018-185 - Rev 00
    301MF10014
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    MOMETASONE FUROATE MONOHYDRATE (D90...
    Mometasone furoate monohydrate
    Mometasone Fluorate Monohydrate at ...
    Issue/Submission Date
    2013-03-29
    2019-08-27
    2019-06-05
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    Budesonide

    PDF Supplier PDF
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    USDMF

    Found USDMF

    22641
    Active
    BUDESONIDE
    2009-03-19
    CEP/COS

    Found CEP/COS

    CEP 2017-138 - Rev 03
    Valid
    Budesonide, Codes 201680 and 201611...
    2024-02-15
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    22641
    CEP 2017-138 - Rev 03
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    BUDESONIDE
    Budesonide, Codes 201680 and 201611...
    Issue/Submission Date
    2009-03-19
    2024-02-15
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    Ciclesonide

    PDF Supplier PDF
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    USDMF

    Found USDMF

    22587
    Active
    CICLESONIDE
    2009-02-27
    CEP/COS

    Found CEP/COS

    R0-CEP 2018-249 - Rev 00
    Valid
    Ciclesonide
    2020-06-23
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    22587
    R0-CEP 2018-249 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    CICLESONIDE
    Ciclesonide
    Issue/Submission Date
    2009-02-27
    2020-06-23
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    Drospirenone

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    USDMF

    Found USDMF

    21733
    Active
    DROSPIRENONE
    2008-06-27
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-193 - Rev 00
    Valid
    Drospirenone
    2015-08-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21733
    R1-CEP 2009-193 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    DROSPIRENONE
    Drospirenone
    Issue/Submission Date
    2008-06-27
    2015-08-20
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    Dutasteride

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    USDMF

    Found USDMF

    20918
    Active
    DUTASTERIDE
    2007-10-08
    CEP/COS

    Found CEP/COS

    CEP 2015-258 - Rev 01
    Valid
    Dutasteride, Form I
    2024-02-06
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20918
    CEP 2015-258 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    DUTASTERIDE
    Dutasteride, Form I
    Issue/Submission Date
    2007-10-08
    2024-02-06
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    Exemestane

    PDF Supplier PDF
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    USDMF

    Found USDMF

    22439
    Active
    EXEMESTANE
    2009-01-21
    CEP/COS

    Found CEP/COS

    R1-CEP 2017-056 - Rev 00
    Valid
    Exemestane
    2023-03-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    22439
    R1-CEP 2017-056 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    EXEMESTANE
    Exemestane
    Issue/Submission Date
    2009-01-21
    2023-03-17
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    Finasteride

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    USDMF

    Found USDMF

    18483
    Active
    FINASTERIDE
    2005-07-06
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-130 - Rev 01
    Valid
    Finasteride
    2017-12-14
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18483
    R1-CEP 2008-130 - Rev 01
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    FINASTERIDE
    Finasteride
    Issue/Submission Date
    2005-07-06
    2017-12-14
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